Following the successful first “patient-attached” trial announced in September 2010, this study further demonstrated the safety and ease of use of the Proxima system and made an initial assessment of analytical performance when integrated into an intravenous fluid line. Readings made with the Proxima system were compared directly with those taken with an existing standard analyser to ensure that the results were both accurate and consistent over time and clinically useful. Using blood drawn from an indwelling cannula, the Proxima device met all the goals for the trial.
The study recruited 13 subjects who each had a single Proxima microanalyser attached. This resulted in measurements on over 200 blood samples in total, analysing simultaneously the clinically important parameters of glucose, pH, carbon dioxide, oxygen and potassium ions. The Proxima system performed very well, accurately reflecting changes in the subjects’ blood chemistry, and proved easy to use with no adverse events being recorded.
The study was undertaken at the clinical trial unit of the West Suffolk Hospital, Bury St. Edmunds, UK. The Chief Investigator was Dr. John Hall, Consultant in Medical Research at West Suffolk Hospital NHS Trust, who observed:
“The performance of the Proxima device exceeded my expectations. It proved easy to use and gave us results in less than a minute after drawing blood. It was remarkable how few problems we had in this trial involving healthy volunteers. We look forward to the next phase, which will be in the intensive care unit and will support application for a CE mark.
The introduction of the Proxima into clinical practice may be the beginning of the end of the practice of carrying blood-filled syringes around the hospital.”
The Proxima system is being developed for critical care applications and uses Sphere Medical’s patented microanalyser technology. The microchip-based system, which can be used to take multiple readings over a period of time, is integrated into existing patient fluid lines to allow the rapid measurement of a panel of blood parameters, including glucose, blood gases and electrolytes required for the management of critically ill patients. Sphere recently received 510(k) clearance form the FDA for a laboratory analyser based on the microanalyser technology.
Dr. Stuart Hendry, CEO of Sphere Medical added:
“This is another great success for Sphere Medical as we start to bring breakthrough products into the hands of clinicians in several areas where there are identified clinical needs. This study is one of a programme of clinical evaluations we have planned for Sphere Medical’s products this year that will lead to regulatory approvals. The relative ease and speed with which this evaluation was performed is testament to the ease of use of the product and its robustness, which augurs very well for the future.”
